Events

Recall of COMPLETE MultiPurpose, 10 Minute, Comfort 8 in 1, Comfort Plus, and Protec

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Medical Optics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36711
  • Event Risk Class
    Class 2
  • Event Number
    Z-0346-2007
  • Event Initiated Date
    2006-09-15
  • Event Date Posted
    2007-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49675
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    contact lens solution - Product Code LPN
  • Reason
    Due to a potential sterility issue with the product container. three lots sold in japan were found to have bacterial contamination, which compromised sterility. because of this production-line issue at the firm''s plant in china, amo is recalling lots that were manufactured on the same production lines during the same production period.
  • Action
    Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.

Device

COMPLETE MultiPurpose, 10 Minute, Comfort 8 in 1, Comfort Plus, and Protec
  • Model / Serial
    No US distribution
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.
  • Product Description
    COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute || (Japan only), Comfort 8 in 1 Solution (Indonesia only), || COMPLETE Comfort Plus All in One Solution (Korea only) & || COMPLETE Protec Formula Multi-Purpose Solution || (Thailand only)
  • Manufacturer
    Advanced Medical Optics, Inc.

Manufacturer

Advanced Medical Optics, Inc.
  • Manufacturer Address
    Advanced Medical Optics, Inc., 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Source
    USFDA